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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03785795
Other study ID # SBIR1.01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2018
Est. completion date January 10, 2020

Study information

Verified date February 2020
Source PreTeL, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.


Description:

The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. Toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor.

Our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. We will accomplish this by applying new knowledge to an old technology - uterine EMG.

This trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment.

The uterus emits bioelectrical signals with each contraction that can be detected by electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG sensor, we call the "area sensor". This sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location.

In this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. Our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor.

Patients with unclear labor status, or those in early labor will be studied. We will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. These data will validate the ability to identify false and true labor using multichannel EMG and area sensors.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Pregnant

- One living fetus

- Experiencing frequent uterine contractions

Exclusion Criteria:

- Cervical dilation > 4 cm

- Ruptured membranes

- Maternal or fetal indications for immediate delivery

Study Design


Intervention

Device:
Uncertain diagnosis of true labor
Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
PreTeL, Inc University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (1)

Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validating prediction of true/false labor status with delivery within 24 hours The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time. 24 hours
Secondary Establishing the range and trend of synchronized sensor readings The fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery 48 hours
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